Invasive treatments for obesity are often recommended for patients with a body mass index (mass/height2 [kg/m2]) which is greater than 35 or 40. For such patients, their weight is commonly associated with increased risk of heart disease, diabetes, and arthritis. Preferably, the invasive treatments are accompanied by changes in lifestyle, such as improved eating habits and an appropriate exercise regimen.
U.S. patent application Ser. No. 09/734,358 to Flesler et al., which published as US Patent Application Publication 2002/0161414, and which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes apparatus for treating a condition such as obesity. The apparatus includes a set of one or more electrodes, which are adapted to be applied to one or more respective sites in a vicinity of a body of a stomach of a patient. A control unit is adapted to drive the electrode set to apply to the body of the stomach a signal, configured such that application thereof increases a level of contraction of muscle tissue of the body of the stomach, and decreases a cross-sectional area of a portion of the body of the stomach for a substantially continuous period greater than about 3 seconds.
PCT Publication WO 02/082968 to Policker et al., which is assigned to the assignee of the present application and is incorporated herein by reference, describes a diet evaluation gastric apparatus, which detects when a patient swallows, and detects the type and amount of matter ingested. The apparatus includes electrodes adapted to be coupled to the fundus and antrum of the patient and to measure electrical and mechanical activity therein, and a control unit to analyze such electrical and mechanical activity and optionally apply electrical energy to modify the activity of tissue of the patient.
U.S. Pat. No. 5,690,691 to Chen et al., which is incorporated herein by reference, describes a gastric pacemaker for treating obesity and other conditions. The pacemaker includes multiple electrodes which are placed at various positions on the gastrointestinal (GI) tract, and which deliver phased electrical stimulation to pace peristaltic movement of material through the GI tract.
U.S. Pat. No. 6,243,607 to Mintchev et al., which is incorporated herein by reference, describes a gastro-intestinal electrical pacemaker, including multiple electrodes which are arranged around a portion of the GI tract. The electrodes stimulate smooth muscle so that local contractions of the portion of the GI tract are artificially propagated therethrough, in order to facilitate a partial emptying of the portion. Preferably, the local contractions are artificially propagated by phase locking or time shifting the electrical stimulus, which is applied to the smooth muscle circumferentially about the portion at two or more locations.
U.S. Pat. No. 5,423,872 to Cigaina, which is incorporated herein by reference, describes apparatus for applying electrical pulses to the distal gastric antrum of a patient, so as to reduce the motility of the stomach and to thereby treat obesity or another condition.
U.S. Pat. No. 5,231,988 to Wernicke et al., which is incorporated herein by reference, describes techniques for treating and controlling diabetes and other systemic pancreatic endocrine disorders attributable to abnormal levels of secretion of endogenous insulin An electrical stimulator implanted into or worn external to the patient's body is adapted, when activated, to generate a programmable electrical waveform for application to electrodes implanted on the vagus nerve of the patient. The electrical waveform is programmed using parameter values selected to stimulate or inhibit the vagus nerve to modulate the electrical activity thereof to increase or decrease secretion of natural insulin by the patient's pancreas. The stimulator is selectively activated manually by the patient in response to direct measurement of blood glucose or symptoms, or is activated automatically by programming the activation to occur at predetermined times and for predetermined intervals during the circadian cycle of the patient. Alternatively, the automatic activation is achieved using an implanted sensor to detect the blood glucose concentration, and is triggered when the patient's blood glucose concentration exceeds or falls below a predetermined level depending on whether diabetes or hypoglycemia is being treated.
U.S. Pat. Nos. 5,188,104 and 5,263,480 to Wernicke et al., which are incorporated herein by reference, describe a method for stimulating the vagus nerve of a patient so as to alleviate an eating disorder.
U.S. Pat. Nos. 6,104,955, 6,091,992, and 5,836,994 to Bourgeois, U.S. Pat. No. 6,026,326 to Bardy, and U.S. Pat. No. 3,411,507 to Wingrove, which are incorporated herein by reference, describe the application of electrical signals to the GI tract to treat various physiological disorders.
PCT Patent Publication WO 99/03533 to Ben-Haim et al., entitled, “Smooth muscle controller,” and U.S. patent application Ser. No. 09/481,253 in the national phase thereof, both of which are assigned to the assignee of the present patent application and are incorporated herein by reference, describe apparatus and methods for applying signals to smooth muscle so as to modify the behavior thereof. In particular, apparatus for controlling the stomach is described in which a controller applies an electrical field to electrodes on the stomach wall so as to modify the reaction of muscle tissue therein to an activation signal, while not generating a propagating action potential in the tissue. In the context of the present patent application and in the claims, the use of such a non-excitatory signal to modify the response of one or more cells to electrical activation thereof, without inducing action potentials in the cells, is referred to as Excitable-Tissue Control (ETC). Use of an ETC signal is described with respect to treating obesity, by applying the ETC signal to the stomach so as to delay or prevent emptying of the stomach. In addition, a method is described for increasing the motility of the gastrointestinal tract, by applying an ETC signal to a portion of the tract in order to increase the contraction force generated in the portion.
U.S. Pat. No. 6,317,631 to Ben-Haim et al., which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes methods for modifying the force of contraction of a heart chamber by applying an ETC signal to the heart.
U.S. Pat. No. 5,716,385 to Mittal et al., which is incorporated herein by reference, describes a crural diaphragm pacemaker for treating gastroesophageal reflux. The pacemaker includes one or more electrodes which are placed in contact with the crural diaphragm, either by implantation or by connecting the electrodes to the skeletal muscles of the crural diaphragm through the skin. During spontaneous intermittent relaxations of the diaphragm, the electrodes stimulate the skeletal muscles of the crural diaphragm, in order to cause contraction of the lower esophageal sphincter.
U.S. Pat. No. 6,535,764 to Imran et al., which is incorporated herein by reference, describes techniques for diagnosing and treating gastric disorders. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment comprises stimulating electrodes for gastric electrical stimulation.
U.S. Pat. No. 4,696,288 to Kuzmak et al., which is incorporated herein by reference, describes calibrating apparatus adapted to be inserted into and proceeded within the stomach of human body. The calibrating apparatus includes a single-lumen tubing terminating in a proximal portion and a distal tip, each of which has an orifice. The single-lumen tubing has a first opening extending therethrough which is located at a selected distance from the proximal portion and a second opening which extends therethrough and which is located a predetermined distance from the distal tip; an elongated, thin-walled sensor having a circular-cross section and a cavity within the interior thereof and which is operatively coupled in a sealing relationship to the distal tip, wherein the thin-walled sensor is capable of having its cross-sectional diameter varied in response to a force applied to the exterior of the sensor to vary the pressure of a fluid within the cavity, and a balloon surrounding the exterior of said single-lumen tubing at the preselected location, which encloses the second opening, and an elongated tubing member which extends through the single-lumen tubing, through the first opening and into communication with the second opening.
U.S. Pat. No. 4,592,339 to Kuzmak et al., which is incorporated herein by reference, describes a gastric band for forming a stoma opening in a stomach for treating morbid obesity. The band is invasively placed around the stomach, and an expandable portion of the band is used to adjust the diameter of the stoma opening.
U.S. Pat. Nos. 5,449,368, 5,226,429, and 5,074,868 to Kuzmak, which are incorporated herein by reference, describe adjustable gastric bands. The size of the stoma opening of the bands can be adjusted by injecting into or removing fluid from an expandable section of the gastric bands.
U.S. Pat. No. 5,601,604 to Vincent, which is incorporated herein by reference, describes a gastric band for placement around the stomach for treating morbid obesity. The inner surface of the band is inflatable through a remote fill port. The band is invasively placed in an encircling position around the stomach by the facile closure of a single fastening means. After the band is fastened around the stomach, a fluid is injected into the inflatable inner surface, thereby constricting the stoma of the stomach.
U.S. Pat. No. 5,658,298 to Vincent et al., which is incorporated herein by reference, describes a tool for tightening a band or ligature having a buckle end and a free end during laparoscopic surgery.
PCT Publication WO 01/83019 to Vincent, which is incorporated herein by reference, describes apparatus and methods for transferring particles and fluids to or from a body of a patient, including inflating a balloon inside the body during surgical procedures to facilitate the identification of anatomical landmarks and to provide guidance for surgical dissections. The apparatus includes an inflation lumen communicating with the balloon, and a transfer lumen in communication with one or more openings. The method permits a surgeon to empty the contents of the stomach, decompress the stomach, inflate the balloon, perform an operation, such as one involving gastric banding or gastric bypass, using the balloon as a landmark, and irrigate the stomach to check for gastric perforations at the end of the surgical procedure.
U.S. Pat. No. 5,938,669 to Klaiber et al., which is incorporated herein by reference, describes an adjustable gastric band for contracting a patient's stomach in order to fight obesity. A gastric band of a known type, implanted around the stomach and including a cavity filled with liquid, is connected by a tube to a control box and a balancing reservoir which are implanted under the skin of the patient. The box contains an electric pump and an electronic control unit capable of communicating by radio with a monitor carried by the patient and with a controller intended for the doctor. The controller can operate the pump by remote control to transfer determined volumes of liquid in a closed circuit from the gastric band to the reservoir or vice versa, to adjust the diameter of a passage in the stomach. The monitor receives and signals alarms from the control box.
U.S. Pat. No. 6,067,991 to Forsell, which is incorporated herein by reference, describes an adjustable gastric band including an elongated non-inflatable restriction member, a forming device for forming the restriction member into at least a substantially closed loop around the stomach or the esophagus to define a restriction opening, and a post-operation non-invasive adjustment device for mechanically adjusting the restriction member in the loop to change the size of the restriction opening.
U.S. Pat. No. 6,210,347 to Forsell, which is incorporated herein by reference, describes a food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient. The device comprises an elongated restriction member to be formed into at least a substantially closed loop defining a restriction opening, and a controllable adjustment device for adjusting the restriction member in the loop to change the size of the restriction opening. The device further comprises a wireless remote control for controlling the adjustment device from outside the body of the patient in a non-invasive manner to assist in treating the patient for morbid obesity.
U.S. Pat. No. 6,460,543 to Forsell, which is incorporated herein by reference, describes a food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient. The device comprises an elongated restriction member forming an expandable and contractible cavity formed into an at least substantially closed loop defining a restriction opening, the size of which is reduced upon expansion of the cavity and increased upon contraction of the cavity. A reservoir containing a predetermined amount of hydraulic fluid and connected to the cavity of the restriction member, and a hydraulic operation device for distributing fluid from the reservoir to the cavity to expand the cavity and for distributing fluid from the cavity to the reservoir to contract the cavity, are also implanted in a patient with morbid obesity and operated from outside the body of the patient in a non-invasive manner. A non-inflatable restriction member may alternatively be used, and hydraulically adjusted.
U.S. Pat. No. 6,453,907 to Forsell, which is incorporated herein by reference, describes an adjustable gastric band that includes an energy transmission device for wireless transmission of energy of a first form from outside the body of the patient. The band is adjusted in response to a second energy form different than the first form to vary the restricted stoma. An energy transfer device is implanted in the patient for transferring energy of the first form transmitted by the energy transmission device into energy of the second form.
U.S. Pat. No. 6,454,699 to Forsell, which is incorporated herein by reference, describes food intake restriction apparatus that includes a restriction device implanted in a patient, which engages the stomach or esophagus to form an upper pouch and a restricted stoma opening in the stomach or esophagus. The apparatus includes a source of energy external to the body of the patient, and a control device for releasing wireless energy from the source of energy from outside the body. The released wireless energy is used in connection with the operation of the restriction device, to enlarge it to allow food passage, or to contract it to substantially prevent food passage. The restriction device optionally includes at least one implanted sensor for sensing at least one physical parameter of the patient, in which case the control device may control the restriction device in response to signals from the sensor.
US Patent Application Publication 2003/0066536 to Forsell, which is incorporated herein by reference, describes food intake restriction apparatus, including an operable restriction device implanted in a patient and engaging the stomach or esophagus to form a restricted stoma opening in the stomach or esophagus. The apparatus includes a source of energy for energizing the restriction device, and a control device for releasing energy from the source of energy from outside the body of the patient. The released energy is used in connection with the operation of the restriction device to vary the size of the stoma opening to allow or substantially prevent the passage of food therethrough. The restriction apparatus optionally includes a pressure sensor for directly or indirectly sensing the pressure in the stomach. The control device may control the restriction device in response to signals from the pressure sensor.
US Patent Application Publication 2001/0011543 to Forsell, which is incorporated herein by reference, describes apparatus for treating morbid obesity or heartburn and reflux disease, including an elongated restriction member formed in a substantially closed loop around a stomach or esophagus of a human to form a stoma opening in the stomach or esophagus. The size of the stoma opening is adjustable by an implanted adjustment device. A control device is utilized to control the adjustment device, in order to either reduce or enlarge the size of the stoma opening, for example in response to the time of the day. A sensor, such as a pressure or position sensor, is surgically implanted in the body of the human so that the sensor may either directly or indirectly sense a physical parameter of the human, such as the pressure in the stomach or the human's orientation with respect to the horizontal. If in response to sensing by the sensor it is determined by the control device that a significant change in the physical parameter has occurred, then the control device controls the adjustment device to either reduce or enlarge the size of the stoma opening.
PCT Publication WO 01/41671 to Cigaina, which is incorporated herein by reference, describes a removable gastric band for controlling obesity by allowing control and/or modification of the diameter of a stomach of a patient. The gastric band comprises a closure mechanism, which allows the elongated body to close around a portion of the stomach. The gastric band can be used in conjunction with a gastric electrostimulator, and is therefore described as being potentially useful for inducing forced slimming in the initial phase of treatment for morbigenous obesity. Such electrostimulation devices may either be incorporated into the removable gastric band or located at a distance from the removable gastric band.
European Patent Application Publication 1 036 545 A2 to Moshe, which is incorporated herein by reference, describes a gastric band for attaching around a circumference of a stomach of a patient, so as to define the diameter of the stomach opening. The band comprises outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof. A through-going opening is made in the elongated member and is located so as to define an end portion of the band having a predetermined length. An opposite end portion of the band is shaped so as to be insertable into the through-going opening, for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.
U.S. Pat. No. 6,511,490 to Robert, which is incorporated herein by reference, describes a gastric banding device for implantation within a person for the treatment of morbid obesity. The gastric banding device includes an inflatable band portion dimensioned to encircle the stomach, and an inflation conduit operable for conducting a percutaneously injected inflation fluid into the band portion. The band portion is a toroidal member having a head end with first fastening means thereon and a tail end having second fastening means thereon and an inflatable shell therebetween. The outer surface of the toroidal shell in reinforced with a non-extensible, biocompatible material which serves to limit outward expansion of the shell when an inflation fluid is injected thereinto. The inner, stomach-contacting surface of the shell has a layer of an open-cell elastomeric foam affixed thereto and integral therewith. In operation, when the band is placed in an encircling relationship with the stomach, the first and second fastening means on the ends of the shell are engaged in locking relationship. An inflation fluid is injected into the shell by means of a subcutaneously implanted injection port that is in fluid communication with the inflation conduit. As the shell expands inwardly, it constricts and compartmentalizes the stomach.
U.S. Pat. No. 6,547,801 to Dargent et al., which is incorporated herein by reference, describes an implantable gastric constriction device comprising a constriction member forming a ring in its operational configuration. The constriction member includes a flexible band, of which the two ends are adjacent to one another in the operational configuration, and a means for actuating the constriction member, characterized in that, in cooperation, on the one hand, at least one end of the flexible band includes a tractile element for moving such end relative to the other end, generating a radial deformation of the constriction member, and, on the other hand, the actuating means comprises a member for pulling the tractile element.
U.S. Pat. No. 5,259,399 to Brown, which is incorporated herein by reference, describes a method and apparatus for causing weight loss in obese patients by occupying a segment of the stomach volume using a variable volume bladder filled with fluid. The bladder is inserted into the upper part of the stomach including the fundus through a percutaneous endoscopic gastrostomy tube, which was non-surgically placed to create a permanent channel to the stomach. The inserted bladder is filled and emptied using a filling system for pumping fluid in and out of the bladder according to a predetermined scheme. The filling system comprises a reversible pump, a two-way valve connected to the filling tube, an electronic control means for automatically controlling the action of the filling system, and a battery. The electronic control means is connected to a plurality of sensors placed on the body of the patient to detect digestion cycle and hemodynamic parameters. The electronic control means collects information detected by the sensors, governs the filling system according to the obtained information and predetermined operation scheme, and records times and volumes of the fluid transferred through the two-way valve.
U.S. Pat. No. 5,234,454 to Bangs, which is incorporated herein by reference, describes a method for controlling the body weight of a patient. The method includes inserting a percutaneous intragastric balloon catheter into the stomach of the patient through a gastrostomy tract. The intragastric balloon catheter comprises elongated shaft means having first and second ends, a first inflatable balloon carried proximal to the first end, and a second inflatable balloon carried proximal to the first inflatable balloon, the second balloon having a lesser inflated volume than the first balloon. The balloon catheter further comprises first and second inflation lumens, first and second inflation ports communicating respectively with the first and second inflation lumens and the first and second balloons, which ports are carried by the second end, and a drainage lumen passing between said first and second ends. The method continues by inflating the first and second balloons within the patient, partially filling the stomach to provide satiety.
U.S. Pat. No. 4,416,267 to Garren et al., which is incorporated herein by reference, describes a stomach insert for treating obesity in humans by reducing the stomach volume. The insert comprises a flexible torus-shaped inflatable balloon having a central opening extending therethrough. At least a portion of the balloon has a self-sealing substance to facilitate puncture thereof with a needle for inflating the balloon and sealing of the puncture upon removal of the needle.
U.S. Pat. No. 6,454,785 to De Hoyos Garza, which is incorporated herein by reference, describes a percutaneous intragastric balloon catheter for the treatment of obesity. The balloon is non-surgically placed in the stomach, and is collocated by percutaneous endoscopic gastrostomy (PEG). The balloon includes a valve for regulating the amount of fluid introduced or evacuated from the balloon.
INAMED Corporation (Santa Barbara, Calif.) manufactures and markets the LAP-BAND® System, an FDA-approved adjustable and reversible gastric band for treatment of obesity.
Glucagon-like-peptide-1 (GLP-1) is a known modulator of insulin secretion in the early phases of a meal and a mediator of satiety. In response to ingestion of a meal, GLP-1 is secreted into the blood by L-cells mainly located in the colon and distal small intestine. Administration of GLP-1, either subcutaneously or peripherally, has been shown to improve glycemic control, partially by restoring the first-phase insulin response and suppressing glucagon, and is therefore considered a potential treatment for obesity and Non-Insulin Dependent Diabetes Mellitus (NIDDM).
Todd J F et al., in an article entitled, “Glucagon-like peptide-1 (GLP-1): a trial of treatment in non-insulin-dependent diabetes mellitus,” Eur J Clin Invest 27 (6):533-6 (1997), which is incorporated herein by reference, write that “GLP-1 has the advantages of both suppressing glucagon secretion and delaying gastric emptying.” They conclude, “GLP-1 improves glycaemic control even in the absence of an insulinotropic effect and is a potential treatment for NIDDM.”
U.S. Pat. No. 6,191,102 to DiMarchi et al., which is incorporated herein by reference, describes pharmaceutical compositions comprising a glucagon-like peptide-1 compound for reducing body weight and treating obesity. The compositions are peripherally administered.
The following articles, which are incorporated herein by reference, may be of interest:
Gutniak M K et al., “Subcutaneous injection of the incretin hormone glucagon-like peptide 1 abolishes postprandial glycemia in NIDDM,” Diabetes Care 17(9):1039-44 (1994)
Robertson M D et al., “The influence of the colon on postprandial glucagon-like peptide 1 (7-36) amide concentration in man,” J Endocrinol 161(1):25-31 (1999)
Schirra J et al., “Mechanisms of the antidiabetic action of subcutaneous glucagon-like peptide-1 (7-36) amide in non-insulin dependent diabetes mellitus,” J Endocrinol 156(1):177-86 (1998)
Todd J F et al., “Subcutaneous glucagon-like peptide-1 improves postprandial glycaemic control over a 3-week period in patients with early type 2 diabetes,” Clin Sci (Lond) 95(3):325-9 (1998)
Vilsboll T et al., “Reduced postprandial concentrations of intact biologically active glucagon-like peptide 1 in type 2 diabetic patients,” Diabetes 50(3):609-13 (2001)